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Monoclonal Antibodies

Durvalumab +/- Lenalidomide for Cutaneous or Peripheral T Cell Lymphoma

Memorial Sloan-Kettering Cancer Center, New York, NY

Targeting 8 different conditionsLenalidomide +2 morePhase 1 & 2RecruitingLed by Christiane Querfeld, MDResearch Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female of childbearing potential: negative urine or serum pregnancy test

Measurable disease per modified severity weighted assessment tool (mSWAT) and/or Sezary count

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 12 months

Awards & highlights

No Placebo-Only Group

Study Summary

This trial is testing durvalumab with or without lenalidomide to treat patients with cutaneous or peripheral T cell lymphoma that has come back and does not respond to treatment.

Eligible Conditions

Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
Sezary Syndrome
Mycosis Fungoides
Cutaneous T-Cell Lymphoma
Cutaneous T-Cell Non-Hodgkin Lymphoma
T-Cell and NK-Cell Non-Hodgkin Lymphoma

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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Your disease has come back after treatment or has not responded to previous treatments.

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You have received and failed to respond to at least two different treatments for your condition. If you have a type of cancer called systemic ALCL, you also must have seen your cancer worsen after receiving brentuximab vedotin treatment.

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If you have a type of skin cancer called MF that cannot be confirmed through a microscope, the doctor will use specific diagnostic criteria recommended by the International Society of Cutaneous Lymphomas to confirm the diagnosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CTCL specific response assessed by Lugano Classification

Dose limiting toxicity assessed by CTCAE version 4.03

Duration of complete response

+7 more

Secondary outcome measures

Pruritus

Other outcome measures

Changes in biomarkers

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (durvalumab, lenalidomide)Experimental Treatment3 Interventions

Patients receive durvalumab IV over 1 hour on day 1 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 (+/- 3) days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (durvalumab)Experimental Treatment2 Interventions

Patients receive durvalumab IV over 1 hour on day 1. Treatment repeats every 28 (+/- 3) days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3030

Lenalidomide

2005

Completed Phase 3

~1480

0 / 20Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

550 Previous Clinical Trials

2,252,504 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,492 Previous Clinical Trials

41,267,519 Total Patients Enrolled

Christiane Querfeld, MDPrincipal InvestigatorCity of Hope Medical Center

Media Library

Durvalumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03011814 — Phase 1 & 2

Peripheral T-Cell Lymphoma Research Study Groups: Arm I (durvalumab), Arm II (durvalumab, lenalidomide)

Peripheral T-Cell Lymphoma Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT03011814 — Phase 1 & 2

Durvalumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03011814 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity for enrollment in this research project?

"Affirmative. The clinical trial is actively recruiting participants, as noted on the clinicaltrials.gov site. It was initially posted on March 8th 2017 and updated recently on January 28th 2022, seeking 62 individuals from 4 different medical sites."

Answered by AI

How many healthcare institutions are conducting this research study?

"This medical experiment is recruiting subjects from M D Anderson Cancer Center, Thomas Jefferson University Hospital, City of Hope Medical Centre and 4 additional sites. Specifically, these are located in Houston (Texas), Philadelphia (Pennsylvania) and Duarte (California son Cancer Center, Thomas Jefferson University Hospital, City of Hope Medical Centre and 4 additional sites. Specifically, these are located in Houston (Texas), Philadelphia (Pennsylvania) and Duarte (California)."

Answered by AI

What medical indications are typically treated with Lenalidomide?

"Lenalidomide is primarily prescribed to treat chronic lymphocytic leukemia, yet it has also been utilized therapeutically for amyloidosis and muscular dystrophy in individuals who have experienced failure under at least two other systemic chemotherapy treatments."

Answered by AI

Are there still open slots for volunteers in this experiment?

"According to the clinicaltrials.gov website, this medical trial is open and recruiting participants since its initial posting on March 8th 2017 and last modification made January 28th 2022."

Answered by AI

Has there been any precedent for using Lenalidomide in research?

"Lenalidomide first hit the clinical research scene in 2004, when Saint Joseph Regional Medical Center-Mishawaka conducted an investigation. Over a thousand studies later, there are presently 598 open studies recruiting participants with many of them taking place in Houston, Texas."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Durvalumab With or Without Lenalidomide in Treating Patients With Relapsed or Refractory Cutaneous or Peripheral T Cell Lymphoma

2017. "Durvalumab With or Without Lenalidomide in Treating Patients With Relapsed or Refractory Cutaneous or Peripheral T Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03011814.

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